Slimline EZ SIS 550 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290109140216), received between Apr 26, 2023 and Jun 13, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) FOR BENIGN PROSTATIC HYPERPLASIA, THE FIBER BROKE AT INSERTION POINT TO SCOPE. A SECOND FIBER WAS TRIED, AND IT BROKE TOO. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS REPORT IS FOR THE SECOND BROKEN FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206882 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) FOR BENIGN PROSTATIC HYPERPLASIA, THE FIBER BROKE AT INSERTION POINT TO SCOPE. A SECOND FIBER WAS TRIED, AND IT BROKE TOO. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS COMPLAINT IS FOR THE FIRST BROKEN FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206610 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THE FIBER WAS PLACED INSIDE THE OPENED ENDED URETERAL CATHETER AND BEING ACTIVELY USED WHEN THE LASER FIBER ITSELF BROKE IN TWO PIECES OUTSIDE THE PATIENT. A LOUD NOISE WAS AUDIBLE IN THE ROOM. THE LASER WAS TURNED OFF AND THE TWO PIECES OF THE LASER FIBER WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489460 ↗
• InjuryApr 26, 2023Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ENERGY IN THE FIBER FIRED INTO THE HAND OF THE PHYSICIAN, CAUSING A BURN; NO INFORMATION WAS PROVIDED ON WHETHER OR NOT TREATMENT WAS ADMINISTERED FOR THE BURN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT COMPLICATIONS. FURTHER INFORMATION OBTAINED INDICATED THAT THE USER IS EXPERIENCING ISSUES WITH THE SCOPES (NON- BSC) USED DURING PROCEDURE. THE SHORT-TERM SOLUTION WITH THE SCOPE ISSUES WAS TO INSERT A SLIM CATHETER INTO THE WORKING CHANNEL OF THE SCOPE TO PREVENT THE LASER RATTLING AROUND DURING PROCEDURE. HOWEVER, THE WORKING CHANNEL APPEARS TO BE TOO LARGE IN DIAMETER.

  Patient problems: Burn(s)

  MAUDE report 16820568 ↗